30-Day Trial of Oral Valtrex or Valtrex Plus Aspirin on Shedding of HSV DNA in Tears and Saliva of Volunteers
Recruitment status was Recruiting
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Purpose
The purpose of this study is to determine whether oral Valtrex alone or in combination with aspirin will reduce the shedding of herpes simplex virus DNA in the tears and saliva from volunteers with no evidence of ocular herpes infection. The secretion of virus into the tears and saliva might make people more susceptible to virus infection in the future if their immune system becomes deficient. The study will also try to determine if there is a correlation between shedding of viral DNA and herpes virus antibodies in serum and to determine if subjects are carriers of a special form of a gene in their blood cells, the presence of which may suggest the possibility of an increased susceptability to herpes and to Alzheimer's disease and heart disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Herpes Simplex |
Drug: valacyclovir hydrochloride Drug: placebo Drug: valacyclovir plus aspirin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | A 30-Day Double-Masked Study to Determine the Effect of Oral Valacyclovir or Oral Valacyclovir Plus Aspirin on the Shedding of Herpes Simplex Virus DNA in the Tears and Saliva of Volunteers Without Clinical Signs of Ocular Herpetic Disease |
- Cessation of DNA shedding above the positive detection threshold [ Time Frame: 30 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2006 |
| Estimated Study Completion Date: | July 2008 |
| Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
placebo, 6 capsules per day for 30 days
|
Drug: placebo
lactose placebo capsule, six per day for 30 days
|
|
Experimental: 2
500 mg Valtrex one capsule per day plus 5 capsules of placebo per day for 30 days
|
Drug: valacyclovir hydrochloride
500 mg capsule, one per day for 30 days
Other Name: Valtrex
|
|
Experimental: 3
500 mg Valtrex capsule one per day, Acetylsalicylic acid (aspirin) 325 mg capsules three per day, plus 2 placebo capsules per day for 30 days
|
Drug: valacyclovir plus aspirin
500 mg valacyclovir capsule, one per day for 30 days 325 mg acetyl salicylic acid (aspirin) capsule, three per day for 30 days placebo capsule, two per day for 30 days
|
Detailed Description:
Published studies have shown that treatment with oral acyclovir reduced clinical recurrences of ocular herpetic keratitis by about 40-50 %8, and treatment with valacyclovir, a more soluble prodrug of acyclovir, reduced the risk of transmission of genital herpes9, 10, 11. For this study, we will use the dose of valacyclovir that was shown effective in reducing the risk of transmission of HSV-2.9 The dose of 325 mg aspirin three times a day was chosen based on our experience with mice and other laboratory animals12. If it is effective and well tolerated at this dose, in future studies we will attempt to use lower doses and determine if they too may be effective.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- either sex
- any race
- over age of 21 years
Exclusion Criteria:
- have active ocular herpetic lesion
- had ocular herpetic lesion in past 30 days
- taking systemic or oral antiviral drugs
- have taken antiviral drugs in the past 30 days
- taking aspirin or NSAIDs
- have dry eyes
- have hypersensitivity to acyclovir or valacyclovir
- have hypersensitivity of contraindication to use of aspirin
- have bleeding disorder
- have GI ulcer
- have kidney impairment
- are pregnant or nursing
- have participated in a clinical trial in the past 30 days
Contacts and Locations| Contact: Emily D Varnell, BS | 504 568-2254 | evarne@lsuhsc.edu |
| Contact: Robin Cooper, BS | 504 568-2815 | rcoope@lsuhsc.edu |
| United States, Louisiana | |
| Children's Hospital | Recruiting |
| New Orleans, Louisiana, United States, 70118 | |
| Principal Investigator: Herbert E Kaufman, MD | |
| LSU Eye Center | Recruiting |
| New Orleans, Louisiana, United States, 70112 | |
| Principal Investigator: | Herbert E Kaufman, MD | LSU Eye Center, LSU Health Sciences Center |
More Information
Publications:
| Responsible Party: | Herbert E Kaufman, MD, Boyd Professor Ophthalmology, Pharmacology, Louisiana State University Health Sciences Center in New Orleans |
| ClinicalTrials.gov Identifier: | NCT00587496 History of Changes |
| Other Study ID Numbers: | 6475, EY002672 |
| Study First Received: | December 21, 2007 |
| Last Updated: | December 21, 2007 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Eye Institute (NEI):
|
HSV DNA volunteers |
Additional relevant MeSH terms:
|
Herpes Simplex Herpesviridae Infections DNA Virus Infections Virus Diseases Skin Diseases, Viral Skin Diseases, Infectious Skin Diseases Aspirin Valacyclovir Acyclovir Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 18, 2013